Category: Audit

5W2H of Process Audits: What You Should Know

We’ve used 5W2H to discuss Product Quality Control before, and now we’re using this popular tool to provide insight regarding process audits.

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Who?

Quality auditors are often certified and/or have other applicable training specific to the types of audits they perform.

Quality auditors must be professional, ethical and objective. They must be able to select appropriate quality and auditing tools and techniques and use them effectively in a variety of applications. In addition, they must verify, document and communicate results.

On-Site: What’s a C-TPAT Security Audit?

security-auditI’ve recently returned from a visit to our offices in China where I was able to attend a C-TPAT audit with our Supplier Development Manager, Jean Champlain.

A C-TPAT audit isn’t quite as common as a general QMS or ISO 9001 evaluation, but the information generated has significant value when you understand the scope.

“C‐TPAT (Customs-Trade Partnership Against Terrorism) seeks to safeguard the world’s vibrant trade industry from terrorists, maintaining the economic health of the U.S. and its neighbors. The partnership develops and adopts measures that add security but do not have a chilling effect on trade, a difficult balancing act.”

When we go on-site for a security audit, here’s the agenda:

Are ISO 13485 and FDA 21 CFR Part 820 audits the same?

Our recent newsletter Feature Article highlighted ISO 13485 audits applicable to the medical device industry.  A common question we receive in relation to regulatory requirements in the U.S. is the relationship to FDA 21 CFR Part 820.

To ensure medical devices are safe and effective, the U.S. Food and Drug Administration regulates current good manufacturing processes (CGMP’s) also known as FDA 21 CFR Part 820.  FDA’s Quality System Regulation Part 820 is harmonized with ISO 13485:1996, which is based on ISO 9001:1994.

According to the FDA,

“The QS regulation applies to finished device manufacturers who intend to commercially distribute medical devices. A finished device is defined in 21 CFR 820.3(l) as any device or accessory to any device that is suitable for use or capable of functioning, whether or not it is packaged, labeled, or sterilized.

Because the regulation must apply to so many different types of devices, the regulation does not prescribe in detail how a manufacturer must produce a specific device. Rather, the regulation provides the framework that all manufacturers must follow by requiring that manufacturers develop and follow procedures and fill in the details that are appropriate to a given device according to the current state-of-the-art manufacturing for that specific device.”

CFR – Code of Federal Regulations Title 21

ISO 13485:201X Preparation (Medical Device Audits)

iso13485ISO 13485:2003 is a standard issued by the International Organization for Standardization that specifies requirements for a medical device manufacturer to maintain a quality management system. According to the standard, these requirements “can be used by an organization for the design and development, production, installation and servicing of medical devices, and the design, development and provision of related services.”

Every few years, ISO issues standard revisions with 13485 originally scheduled for release this year.  However, due to the high volume of comments received by the ISO Technical Committee, the 13485 revision is planned for early 2016. It is currently referred to as ISO 13485:201X, or DIS (Draft in Standard).

The proposed revisions are significant, and it is important for medical device organizations to start preparing now.  Three changes that are speculated include:

1) Due to to the increasing complexity of the international regulatory environment for medical devices, it is expected that ISO 13485:201X will incorporate EN ISO 13485:2012 elements and reflect more current requirements by the EU.